NDA 22407, held by Theravance Inc. Telavancin.
As of Nov 14, 2026, NDA 22407 (Vibativ), held by Theravance Inc, was first approved by FDA on Jun 21, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2013 | Original applicationNew indication · Standard review | Approved |
| Vibativ250MG · injectable; injection | Telavancin | Rx |
| Vibativ750MG · injectable; injection | Telavancin | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
